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510(k) Data Aggregation

    K Number
    K181277
    Device Name
    E-CUBE 12
    Manufacturer
    Alpinion Medical Systems Co., Ltd.
    Date Cleared
    2018-09-28

    (137 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K172732,K161439,K150773,K173713
    Predicate For
    K200449,K200450
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal, Abdominal (renal & GYN/pelvic), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).

    Device Description

    E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

    AI/ML Overview

    The acceptance criteria and study proving the device meets them are described in the Summary of Non-Clinical Tests.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standards Met)Reported Device Performance
    IEC60601-1:2005 (Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012 (Medical Electrical Equipment - Part 1: General Requirements for Safety)Conforms to this standard.
    IEC60601-1-2 Edition 3:2007-03 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests)Conforms to this standard.
    IEC60601-2-37 Edition 2.0:2007 (Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)Conforms to this standard.
    AAMI/ANSI/ISO10993-1:2009(R)2013 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing)Transducer materials and other patient contact materials are biocompatible. Conforms to this standard.
    AAMI/ANSI/ISO14971:2007/(R)2010 (Medical devices-Application of risk management to medical devices)Conforms to this standard, as evidenced by the application of medical device risk management.
    AIUM MUS, Third edition (Medical Ultrasound Safety)Conforms to this standard.
    NEMA UD 2-2004(R2009) (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment)Conforms to this standard. Acoustic output was evaluated.
    NEMA UD 3-2004(R2009) (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment)Conforms to this standard. Thermal and electrical safety were evaluated.

    2. Sample size used for the test set and the data provenance:
    Not applicable. The document states, "The subject of this premarket submission, E-CUBE 12, did not require clinical studies to support substantial equivalence." The evaluation was based on non-clinical tests and conformance to established standards.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
    Not applicable. No clinical studies were conducted for this submission, and therefore no "experts" were used to establish ground truth in a clinical sense.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
    Not applicable. No clinical studies were conducted for this submission.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
    Not applicable. The device is an ultrasound imaging system, and the submission does not mention any AI capabilities or MRMC studies.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
    Not applicable. The device is an ultrasound imaging system, and the submission does not mention any standalone algorithm performance studies. The evaluation focused on the physical device's adherence to safety and performance standards.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
    The "ground truth" for this submission is adherence to established international and national voluntary standards for medical devices, specifically regarding safety (thermal, electrical, electromagnetic, mechanical), biocompatibility, and acoustic output. There is no biological or diagnostic ground truth established by experts or pathology for a clinical study in this document.

    8. The sample size for the training set:
    Not applicable. The document does not describe any machine learning or algorithm development that would involve a training set. The evaluation is based on engineering and safety standards compliance.

    9. How the ground truth for the training set was established:
    Not applicable. As there is no mention of a training set, the establishment of its ground truth is not relevant here.

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